OSD COP Resources

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These resources are just one of the many benefits of being an OSD COP Member.
Join the OSD COP and ask questions in the community discussions and gain solutions to real-world problems. Also, share your experience and expertise by responding to inquiries.

Note that only ISPE Members can engage in these activities.  If you are not an ISPE Member, join ISPE and take advantage of all the benefits that membership has to offer.

  • Baseline Guide OSD Vol 2 Revision Presentation ( 875 KB)
    Presentation on the development of the OSD Baseline Guide Vol 2 revision.
  • Intro to OSD - 101 ( 2 MB)
    This presentation, previously presented at the ISPE Conference in Tampa, FL is a very general and high level introduction to Oral Solid Dose Form Manufacturing.
  • OSD Primary Unit Operations Matrix ( 269 KB)
    The OSD Primary Unit Operations Matrix is a graphical tool that shows the typical operations in an OSD Manufacturing Process. It identifies the three primary processing methods for Tablets and Capsules. It is intended to provide a high level overview of OSD. It does not account for all possible operations and is for General Reference only.  This document was created by Dave DiProspero of Stantec Consulting.
  • Guide to Inspections of Oral Solid Dosage Forms
    This is the FDA guideline on OSD Inspections
  • Process Validation: General Principles and Practices
    FDA Guideline-2011
  • ANVISA GMP Revision ( 335 KB)
    Brazil’s National Health Surveillance Agency (ANVISA) is revised its Good Manufacturing Practices for Medications in 2009.  The revisions include a section on production practices for the prevention of bacterial and cross contamination.

 


Indicates content available to ISPE members only.